Good Laboratory Practice (eBook)

I. What is Good Laboratory Practice All About?- 1. Introduction.- 2. The History of GLP.- 2.1 The Early Days and the Causative Events.- 2.2 The First Regulations.- 2.3 International Ripples: The OECD Principles.- 2.4 The Principles and Their Interpretation.- 2.5 Closing the Circle? – The Detection of Test Item in Control Samples.- 3. The Idea Behind GLP.- 4. The Areas of Application.- 5. The Pillars of Good Laboratory Practice.- 6. Where Can GLP be Profitably Applied?- 7. GLP and Other Laboratory Quality Systems.- II. How is Good Laboratory Practice Regulated?- 1. Introduction.- 2. Definitions in GLP.- 2.1 Good Laboratory Practice.- 2.2 Management.- 2.3 Study Director and Principal Investigator.- 2.4 Test Facility and Test Site.- 2.5 The Study.- 2.6 Short-Term Studies.- 2.7 Initiation, Starting and Completion Dates.- 2.8 Study Plan, Amendments and Deviations.- 2.9 Raw Data 94.- 2.10 The Phases of a Study.- 2.11 The Master Schedule.- 2.12 Test and Reference Item.- 2.13 Additional Definitions.- 3. Responsibilities in Good Laboratory Practice.- 3.1 Management.- 3.2 Study Director and Principal Investigator.- 3.3 Study Personnel.- 3.4 The Sponsor.- 4. The Quality Assurance Programme.- 4.1 General Considerations.- 4.2 Quality Assurance Inspections.- 4.3 Quality Assurance Inspection Reports.- 4.4 Audits of Raw Data and of Final Reports.- 4.5 The Quality Assurance Statement.- 5. Facilities.- 5.1 General Requirements.- 5.2 Test System Facilities.- 5.3 Facilities for Handling Test and Reference Items.- 5.4 Archive Facilities.- 6. Apparatus, Materials and Reagents.- 7. Computerised Systems.- 7.1 Introduction.- 7.2 Basic Considerations.- 7.3 Data considerations.- 7.4 Prospective Validation.- 7.5 Retrospective Evaluation.- 7.6 Maintenance and Change Control.- 7.7 Security.- 7.8 Levels of Complexity.- 8. Test Systems.- 8.1 Physical/Chemical Test Systems.- 8.2 Biological Test Systems.- 9. Test and Reference Items.- 9.1 Handling andDocumentation.- 9.2 Characterisation.- 9.3 Expiry Dates.- 9.4 Sample Retention.- 10. Standard Operating Procedures.- 10.1 Introduction.- 10.2 The Format.- 10.3 Issue, Approval and Distribution.- 10.4 On-line SOPs.- 10.5 The Content.- 10.6 Where are SOPs required?- 11. Study Performance and Reporting.- 11.1 The Study Plan.- 11.2 Study Conduct.- 11.3 The Final Report.- 11.4 Re-opening and Amending a Study.- 11.5 Discontinued Studies.- 12. The Archives.- 12.1 Storage Period.- 12.2 Indexing and Retrieval.- 12.3 Security.- 12.4 Archiving of Electronic Raw Data.- 12.5 Archive location, merging and dissolution.- III. How can Good Laboratory Practice be Introduced in a Test Facility?- 1. Introduction.- 2. General Aspects.- 3. A General Way to Implementation.- 3.1 The preliminaries.- 3.2 The organisation.- 3.3 Separation and distribution of facilities and equipment.- 3.4 Interlude: Personnel documentation.- 3.5 Distributing Responsibilities.- 3.6 The Major Task: Standard Operating Procedures.- 3.7 Second Interlude: Quality Assurance and IT.- 3.8 The Personnel: Education and Training.- 3.9 Study Plans.- 3.10 Test and Reference Item Issues.- 3.11 Study Conduct.- IV. How is Compliance with Good Laboratory Practice Monitored?- 1. Introduction.- 2. National Monitoring Authorities.- 3. MOUs, MRAs, and MJVs.